MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. EMERALD SERIES; SURGICAL ADJUNCTS

Model Number EMERALD

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information; patient weight, and ethnicity and race: unknown as information was asked but not provided.Device lot number: unknown as information was not provided.Expiration date: unknown as product lot number was not provided.Udi number: a complete udi number is unknown as product lot number was not provided.Date implanted: not applicable, as the cartridge is not an implantable device.Date explanted: not applicable, as the cartridge is not an implantable device.Device manufacture date : unknown as product lot number was not provided.Device lot number is not available; therefore, no further investigation can be performed.In addition, the device was not returned for analysis.Therefore, a visual analysis of the complaint device cannot be completed.If there is any further relevant information received, a supplemental medwatch report will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the emerald cartridge caused the intraocular lens (iol) trailing haptic to crimp.Account indicated that the iol did not appear to be centered within the capsular bag.The lens was fully inserted and removed.It was provided that the incision was enlarged to remove the lens.No further issues were reported.The procedure was completed successfully using a backup lens with the same model and diopter size.Patient status post-procedure was reported as healing well.No further information is available.

• Brand Name: EMERALD SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13428229
• MDR Text Key: 292062825
• Report Number: 3012236936-2022-00287
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMERALD
• Device Catalogue Number: EMERALDC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ZA9003 LENS, SN: (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Sex: Male